A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, five approvals were added from Europe, Israel and Japan.
Five novel device approvals were added to Medtech Insight's Approvals Tracker last week, including three European CE marks for coronary dilation balloon catheters made by SIS-Schwager Medica-SIS.
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Also last week, Check-Cap LTD, announced Israeli approval of its C-Scan ingestible capsule for colorectal cancer screening, and BTG, along...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
